By Kirell Lakhman

SAN JOSE, Calif. — A lab director at a leading New York medical center let loose a blast of controversy today during a session at this year's annual AMP conference, held here this week, after suggesting the NIH's impending genetic-testing registry is superfluous and questioning its "credibility" because the chief of staff of the agency's head looks down upon lab-developed tests.

Moreover, an NIH official who was a co-presenter of the session, which discussed the results of a survey AMP conducted with its members about the registry, said "I don't disagree with you."

(In an e-mail in early January 2011, the official, Cathy Fomous, a senior health science policy analyst at the NIH's Office of Biotechnology Activities, said her remark did not encompass the LDT opinion.)

"Why are you doing this [registry]?" said Debra Leonard, left, director of clinical laboratories and pathology residency training at Weill Cornell Medical Center, during a question-and-answer period following the session.

Leonard, who is also a professor of pathology and vice chair for laboratory medicine at the Weill Cornell Medical College, complained that neither NIH nor AMP, which supports the registry, had provided clear communication about the GTR to the clinical lab community.

She also suggested the registry would be superfluous given the fact that two existing databases, GeneTests, which is overseen by NIH, and a test directory run by AMP, provide essentially the same service that the GTR would offer.

"We already have GeneTests and the AMP test directory, so why do we need the [GTR]?" Leonard said from behind one of two microphones placed in an aisle of the session room.

This post's headline says Leonard's remarks "sparked controversy" because the session during which she made them reported on results of a Nov. 2 NIH meeting that discussed the GTR, and an AMP survey that preceded it. The results of the survey suggest general support for the GTR. I plan to write about the session and the survey results at a later date.

'Credibility Issue'

Supporting her claim that the GTR has a "credibility issue," Leonard said Kathy Hudson, chief of staff for NIH Director Francis Collins who is helping to develop the registry, does not support LDTs.

According to Leonard, Hudson, left, a former aide to Collins who went on to found and direct the highly respected Genetics & Public Policy Center at John's Hopkins University, poses a conflict of interest for the registry.

Leonard said Hudson, who is helping to form the GTR, believes LDTs are inferior to IVDs — a remark, if true, could undermine the GTR's efforts to be an objective, all-inclusive repository of data.

Leonard went on to say that her own research has shown that there is "no difference" between the quality of LDTs and IVDs.

Both kinds of tests would be included in the registry, according to its preliminary outline.

Responding to Leonard's remarks, Fomous said "I don't disagree with you," and explained that "as far as I know" the registry is being created "to consolidate the existing databases and be a one-stop-shop" for genetic tests.

Hudson, who was appointed last month to the newly created position of NIH Deputy Director for Science, Outreach, and Policy, has been a vocal supporter of making the GTR mandatory.

This is a point of contention with AMP, which has said it strongly supports a voluntary database.

Hudson was not immediately available for comment about her stance on LDTs because it is after hours on a weekend in California, and she works on the East Coast.

In the past Hudson has said she believes the need for a government-run genetic-test registry "has been exacerbated by the widespread availability of genetic tests and by increased marketing of these products directly to consumers by personal genomics firms," my colleague Turna Ray reported in July 2009.

According to Ray, the GPPC outlined its own version of a mandatory registry in a paper published the previous month. The paper recommended that the registry include information on the analytical validity, clinical validity, clinical utility, and proficiency testing of not only LDTs, but IVD test kits and even DTC genetic tests.

As I wrote in March, NIH's decision to ensure the GTR remain voluntary was a wise move because a mandatory registry would shoulder the fledgling genetic-testing industry — both its private and public sectors — with an unbalanced burden of disclosure.

Following the session, Leonard was swarmed by colleagues who said such things as "You said what everyone was thinking;" "well done;" and "thank you for asking that."

When I asked her if she thought what she said was provocative, Leonard said "no," adding that "many people here tonight were thinking the same thing. All I did was say it."

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